Author: David P. JaquesPublisher:
ISBN:
Category :
Languages : en
Pages : 234
Book Description
Prospective Randomized Clinical Trials in Oncology
Author: David P. JaquesProspective Randomized Clinical Trials in Oncology
Author: David P. JaquesSmall Clinical Trials
Author: Institute of MedicinePublisher: National Academies Press
ISBN: 0309171148
Category : Medical
Languages : en
Pages : 221
Book Description
Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
Textbook of Clinical Trials in Oncology
Author: Susan HalabiPublisher: CRC Press
ISBN: 1351620967
Category : Medical
Languages : en
Pages : 701
Book Description
There is an increasing need for educational resources for statisticians and investigators. Reflecting this, the goal of this book is to provide readers with a sound foundation in the statistical design, conduct, and analysis of clinical trials. Furthermore, it is intended as a guide for statisticians and investigators with minimal clinical trial experience who are interested in pursuing a career in this area. The advancement in genetic and molecular technologies have revolutionized drug development. In recent years, clinical trials have become increasingly sophisticated as they incorporate genomic studies, and efficient designs (such as basket and umbrella trials) have permeated the field. This book offers the requisite background and expert guidance for the innovative statistical design and analysis of clinical trials in oncology. Key Features: Cutting-edge topics with appropriate technical background Built around case studies which give the work a "hands-on" approach Real examples of flaws in previously reported clinical trials and how to avoid them Access to statistical code on the book’s website Chapters written by internationally recognized statisticians from academia and pharmaceutical companies Carefully edited to ensure consistency in style, level, and approach Topics covered include innovating phase I and II designs, trials in immune-oncology and rare diseases, among many others
Clinical Trials in Oncology, Third Edition
Author: Stephanie GreenPublisher: CRC Press
ISBN: 1439814481
Category : Mathematics
Languages : en
Pages : 266
Book Description
The third edition of the bestselling Clinical Trials in Oncology provides a concise, nontechnical, and thoroughly up-to-date review of methods and issues related to cancer clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the pitfalls inherent in these processes. In addition, the book has been restructured to have separate chapters and expanded discussions on general clinical trials issues, and issues specific to Phases I, II, and III. New sections cover innovations in Phase I designs, randomized Phase II designs, and overcoming the challenges of array data. Although this book focuses on cancer trials, the same issues and concepts are important in any clinical setting. As always, the authors use clear, lucid prose and a multitude of real-world examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Armed with Clinical Trials in Oncology, Third Edition, clinicians and statisticians can avoid the many hazards that can jeopardize the success of a trial.
A National Cancer Clinical Trials System for the 21st Century
Author: Institute of MedicinePublisher: National Academies Press
ISBN: 0309157870
Category : Medical
Languages : en
Pages : 317
Book Description
The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research.
Randomized Phase II Cancer Clinical Trials
Author: Sin-Ho JungPublisher: CRC Press
ISBN: 143987185X
Category : Mathematics
Languages : en
Pages : 250
Book Description
In cancer research, a traditional phase II trial is designed as a single-arm trial that compares the experimental therapy to a historical control. This simple trial design has led to several adverse issues, including increased false positivity of phase II trial results and negative phase III trials. To rectify these problems, oncologists and biostatisticians have begun to use a randomized phase II trial that compares an experimental therapy with a prospective control therapy. Randomized Phase II Cancer Clinical Trials explains how to properly select and accurately use diverse statistical methods for designing and analyzing phase II trials. The author first reviews the statistical methods for single-arm phase II trials since some methodologies for randomized phase II trials stem from single-arm phase II trials and many phase II cancer clinical trials still use single-arm designs. The book then presents methods for randomized phase II trials and describes statistical methods for both single-arm and randomized phase II trials. Although the text focuses on phase II cancer clinical trials, the statistical methods covered can also be used (with minor modifications) in phase II trials for other diseases and in phase III cancer clinical trials. Suitable for cancer clinicians and biostatisticians, this book shows how randomized phase II trials with a prospective control resolve the shortcomings of traditional single-arm phase II trials. It provides readers with numerous statistical design and analysis methods for randomized phase II trials in oncology.
The Prevention and Treatment of Missing Data in Clinical Trials
Author: National Research CouncilPublisher: National Academies Press
ISBN: 030918651X
Category : Medical
Languages : en
Pages : 163
Book Description
Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.
Clinical Trials in Surgical Oncology, An Issue of Surgical Oncology Clinics of North America, E-Book
Author: Elin R. SigurdsonPublisher: Elsevier Health Sciences
ISBN: 0323546935
Category : Medical
Languages : en
Pages :
Book Description
This issue of Surgical Oncology Clinics of North America, guest edited by Dr. Elin R. Sigurdson, is devoted to Clinical Trials in Surgical Oncology. Dr. Sigurdson has assembled expert authors to review the following topics: Commentary on Randomized Controlled Trials; Randomized Clinical Trials in Soft Tissue Sarcoma; Randomized Clinical Trials in Gastrointestinal Stromal Tumors; Randomized Clinical Trials in Melanoma; Randomized Clinical Trials in Breast Cancer; Randomized Clinical Trials in Gastroesophageal Carcinoma; Randomized Clinical Trials in Hepatocellular Carcinoma; An Update on Randomized Clinical Trials in Advanced and Metastatic Colorectal Carcinoma; Randomized Clinical Trials in Colon and Rectal Cancer; Randomized Clinical Trials in Anal Cancers; The Elderly in Randomized Clinical Trials; Hereditary Syndromes in Clinical Trials; Future Clinical Trials: Genetically Driven Trials; Randomized Clinical Trials in Neuroendocrine Tumors, and more!
Randomized Clinical Trials in Surgical Oncology, An Issue of Surgical Oncology Clinics -- E-Book
Author: Adam C. YoppPublisher: Elsevier Health Sciences
ISBN: 145570069X
Category : Medical
Languages : en
Pages : 249
Book Description
This issue of the Surgical Oncology Clinics will review the important clinical trials from the past eight years in following topics: breast cancer, soft tissue sarcoma, rectal and anal carcinoma, pancreatic adenocarcinoma, hepatocellular carcinoma, gastric cancer, esophageal cancer, colon cancer, advanced and metastatic colorectal carcinoma, gastrointestinal stromal tumors, and melanoma.